Table 4.
Safety and adverse events (AEs) in cirrhotic patients enrolled in part 2 (all patients as treated; initial treatment phase through follow-up week 4)
| AEs | Cirrhotic patients (n = 35) |
|---|---|
| Events of clinical interest | 3 (8.6%) |
| ≥1 AEsa | 28 (80%) |
| Nasopharyngitis | 5 (14.3%) |
| Increased ALT level | 5 (14.3%) |
| Increased AST level | 5 (14.3%) |
| Rash | 3 (8.6%) |
| Constipation | 3 (8.6%) |
| Diarrhea | 3 (8.6%) |
| Malaise | 2 (5.7%) |
| Anemia | 2 (5.7%) |
| Headache | 2 (5.7%) |
| Drug-related AEsb | 13 (37.1%) |
| SAEs | 0 (0%) |
| Discontinuation because of AEs | 0 (0%) |
| Deaths | 0 (0%) |
| ALT | |
| 1.1–2.5 times baseline level | 2 (5.7%) |
| >2.5–5.0 times baseline level | 2 (5.7%) |
| >5.0 times baseline level | 1 (2.9%) |
| AST | |
| 1.1–2.5 times baseline level | 3 (8.6%) |
| >2.5–5.0 times baseline level | 1 (2.9%) |
| >5.0 times baseline level | 1 (2.9%) |
| Total bilirubin | |
| >2.5–5.0 times baseline level | 0 (0%) |
| >5.0–10.0 times baseline level | 0 (0%) |
| >10.0× baseline | 0 (0%) |
| Alkaline phosphatase | |
| 1.1–2.5 times baseline level | 7 (20%) |
| >2.5–5.0 times baseline level | 0 (0%) |
| >5.0 times baseline level | 0 (0%) |
ALT alanine aminotransferase, AST aspartate aminotransferase, SAEs serious AEs
aIncidence greater than 5%
bAll mild intensity. The drug-related AEs most commonly reported for 5% of patients were increased ALT level (14.3%, 5/35), increased AST level (14.3%, 5/35), diarrhea (8.6%, 3/35), constipation (5.7%, 2/35), and malaise (5.7%, 2/35)